Duns Number:330119702
Catalog Number
31017
Brand Name
Golden Sun
Version/Model Number
F71 T12 100W
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LEJ
Product Code Name
Booth, Sun Tan
Public Device Record Key
628008aa-ca45-4083-850e-5fb15118b517
Public Version Date
December 13, 2019
Public Version Number
2
DI Record Publish Date
September 05, 2019
Package DI Number
54014501404152
Quantity per Package
25
Contains DI Package
04014501004159
Package Discontinue Date
December 11, 2019
Package Status
Not in Commercial Distribution
Package Type
Tertiary Packaging
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 446 |